510(k) K193202 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
EXALT Model D Single-Use Duodenoscope, EXALT Controller
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Dec 13, 2019 |
| Received | Nov 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193202
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2023 | Boston Scientific Corporation EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0. Open, Classified |
FDT | None listed |
| Nov 21, 2023 | Boston Scientific Corporation EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0. Open, Classified |
FDT | None listed |
| Mar 3, 2022 | Boston Scientific Corporation EXALT Model D Single- Use Duodenoscope (Box 1)
UPN: M00542420
Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perf Open, Classified |
FDT | None listed |
| Mar 3, 2022 | Boston Scientific Corporation EXALT Model D Single- Use Duodenoscope (Box 2)
UPN: M00542421
Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perf Open, Classified |
FDT | None listed |
| Mar 3, 2022 | Boston Scientific Corporation EXALT Model D Single-Use Duodenoscope (Box 1)
UPN:M0054242CE0
Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perfor Open, Classified |
FDT | None listed |
| Mar 3, 2022 | Boston Scientific Corporation EXALT Model D Single-Use Duodenoscope (Box 2)
UPN: M0054242CE1
Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perf Open, Classified |
FDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.